Skip to main content
Clinical Trials/NCT03866135
NCT03866135
Completed
Not Applicable

The Relationship Between Bone Mineral Density, Disease Duration, and Activity in Patients With Ankylosing Spondylitis

Bezmialem Vakif University1 site in 1 country111 target enrollmentJuly 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ankylosing Spondylitis
Sponsor
Bezmialem Vakif University
Enrollment
111
Locations
1
Primary Endpoint
Bath ankylosing spondylitis disease index (BASDAI)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Our clinical study aimed to evaluate the prevalence of osteoporosis (OP) in patients with ankylosing spondylitis (AS) and to investigate the relationship between clinical, disease activity, physical function and disease duration, and bone mineral density (BMD).

Detailed Description

In this cross-sectional study, patients who were admitted to the rheumatology clinic between 18 and 65 years of age and diagnosed as AS according to the modified New York diagnostic criteria were included Patients group was divided two part as patients with (group 1)and without (group 2) osteoporosis. The patient's global rating scale is a self-assessed scale of the patient with a grade of 10 (1: very bad, 5: moderate, 10: very good). To assess the disease activity, Bath ankylosing spondylitis disease index (BASDAI) and Bath ankylosing spondylitis functional index (BASFI) were evaluated. BASDAI is a self-assessment scale used to determine disease activity in patients with AS. Schober measurement was used to evaluate lumbar mobility of the patients. Chest expansions were measured in all patients. Body mass index (BMI) was calculated as kg/height m2. Erythrocyte sedimentation rate (ESH mm / h), C-reactive protein (CRP mg / l) levels were measured in all patients. BMD measurements were made by using dual-energy x-ray absorptiometry (DEXA) and lumbar vertebra (L1-4) and left femur (femoral neck and total) regions. DEXA measurements (GE / LUNAR DPX PRO) were performed and the results were recorded using standard T score. Bone mineral densities of patients were based on the World Health Organization (WHO) classification of a T score between -1 and -2.5 for osteopenia; and a score of -2.5 for osteoporosis.

Registry
clinicaltrials.gov
Start Date
July 1, 2018
End Date
January 31, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yaşar Keskin

Department of Physical Medicine and Rehabilitation, Principal Investigator, Medical Doctor

Bezmialem Vakif University

Eligibility Criteria

Inclusion Criteria

  • Patients diagnosed as AS according to the modified New York diagnostic criteria were included

Exclusion Criteria

  • Patients previously diagnosed with OP,
  • Patients previously treated with OP,
  • Patients with bone fractures previously associated with OP,
  • Those using drugs that affect bone metabolism, metabolic bone diseases (Paget's -disease, osteomalacia, hyperparathyroidism),
  • Diabetes mellitus,
  • Hypothyroidism, hyperthyroidism,
  • Patients with kidney, liver and intestinal diseases,
  • Those using corticosteroids

Outcomes

Primary Outcomes

Bath ankylosing spondylitis disease index (BASDAI)

Time Frame: up to 6 month

BASDAI, is a widely used patient-reported outcome to measure disease activity in AS. It comprises only six questions (Box 5.1). The answers to these questions are scored on a 0-10 NRS, which are anchored by 0 ("none") to 10 ("very severe"). The BASDAI sum score is calculated by the sum of questions 1-4 plus mean of questions 5 and 6, the total then divided by 5. The sum score ranges from 0 to 10, higher values indicate more active disease.

Bath ankylosing spondylitis functional index (BASFI)

Time Frame: up to 6 month

Bath Ankylosing Spondylitis Functional Index (BASFI): this is the most frequently used tool to asses function in AS. It contains 10 questions on activities of daily living, which are scored with a rating scale from 0 (no functional impairments) to 10 (maximal impairment). The sum score ranges from 0 to 10, with higher values indicating worse functioning.

Study Sites (1)

Loading locations...

Similar Trials